Medicines and Healthcare products Regulatory Agency Market Towers 1 Nine Elms Lane, London SW8 5NQ
Mr Medawar Social Audit Ltd P.O. Box 111 London NW1 8XG	General enquiries Telephone 020 7273 0000  Fax 020 7273 0353 E-mail [email protected] www.mhra.gov.uk

  

27 February 2007 Dear Mr Medawar,                                                                                                                         FOI 07/034

Thank you for your e-mail of 29th January requesting information concerning the MHRA investigation into GlaxoSmithKline in connection with its alleged failure to supply pharmacovigilance information to the MHRA relating to the paediatric use of Seroxat (paroxetine).  MHRA has considered your request under the provisions of the Freedom of Information Act 2005 and I am pleased to be able to provide the following response. Q1    What is the current status of the investigation for possible criminal prosecution of GlaxoSmithKline, in connection with its alleged failure to supply pharmacovigilance information to the MHRA relating to the paediatric use of Seroxat (paroxetine)?  A     The investigation is still on-going and the MHRA cannot comment further at this stage. Q2   When was the decision to investigate first taken, and has the Agency's investigation yet been concluded? If so, have all relevant papers yet been forwarded to prosecuting lawyers within the DoH, and when was this done? If not, by what date would you expect to provide prospecting lawyers to be provided with the relevant information? A     The investigation commenced on 1st October 2003. The investigation is ongoing, it will continue until the relevant lines of enquiries have been concluded. Thereafter a decision will be made by departmental solicitors. Q3    Has any decision been made either to prosecute GSK or not to do so? When was that decision made, by which organisation(s), and on what date was it publicly announced and how? A      No decision has yet been made on whether or not to prosecute GSK. Q4    How many MHRA staff (including its agents) have been substantially involved in preparing the case were involved, and what has been the estimated cost to the Agency of the investigations made? A     The numbers of people, both MHRA and external, that have worked on the investigation has varied as the investigation has progressed depending upon which particular tasks needed to be carried out at any particular time. Typically the number of people involved has varied between 4 and 10.  It is not possible to give a figure for what the estimated cost of the investigation is as the investigation has not concluded. I hope this is helpful, Yours sincerely, MHRA.

The MHRA responded to this FOI request on 4 April 2007. It appears that the statement the Agency gave to Panorama meant almost nothing – in that the reported “substantial additional resources” allocated to the investigation of GlaxoSmithKline were nothing new. Whatever they amount to, they had been there all along – i.e. there is no new urgency to the investigation and it’s proceeding as before. The Agency’s response was as follows:

1. The statement made concerning the substantial additional resources given to the investigation was originally made in July 2005. The MHRA spokesperson was accurately reported, the position described has been true from the outset of the investigation, substantial additional resources have been allocated to this investigation, this includes investigators, lawyers,  pharmacovigilance specialists and other internal and external expertise as required.

2. When was the decision taken to deploy substantial additional resources to the investigation?  A. From the commencement of the investigation, resources were kept constantly under review and when additional needs were identified, these were addressed at that time.
           
3. Was this decision [a] formally communicated to; and/or [b] formally approved by either the MHRA Executive Board or the Agency Board and if so when? A. The Chief Executive has been kept informed on a regular basis of the progress of this investigation, including issues concerning the deployment of resources.

4. Please clarify the meaning of ‘substantial’, in this context, by reference to [a] the number(s) of people and/or person days newly assigned to the investigation; and [b] the resulting increase in capacity, expressed as a proportion of the resources previously allocated to this investigation.  A. I believe this is covered in the response to FOI 07/034 - copied for your reference.

5. Were any existing Agency personnel or others recruited to the MHRA, and newly assigned to the investigation, formally advised that they would be so employed? If so, how many people had been so notified in the nine month period preceding this announcement?  A. All members of the team were aware that they were assigned to this particular investigation.

6. Please explain why no reference to the substance of the statement reported by Panorama was made in response to my FOI request 07/34.  A. As we have stated, the statement concerning the investigation being given substantial additional resources dates back to July 2005. There have been no further additional resources allocated since the statement given to the Panorama programme.


Kind Regards

Lynda Scammell

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